ProClinical is advertising a vacancy for a Validation Engineer position with a leading global pharmaceutical company. This organization, which develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, is seeking for the Validation Engineer to join their team in Maryland.
The Validation Engineer's primary responsibility will be to support Data Integrity (DI) activities associated with computerized laboratory instruments. These include data integrity assessments, identification of corrective actions, and remediation of gaps for analytical instruments across manufacturing and laboratory areas.
- Supporting the completion of standardized system assessment tool with key stakeholders for all analytical instruments.
- Developing CAPA plans and performing corrective actions to address DI findings.
- Authoring and/or revising analytical instrument User Requirements Specifications to align with DI and standards.
- Authoring final reports summarizing execution of analytical instrument qualification protocols.
- Authoring support documents (amendments, repeat test forms, addenda and deviations) in support of analytical instrument qualifications.
- Ensuring compliance with and completion of deliverables as specified within the Data Integrity Plan.
- Ensuring analytical instruments are maintained in a qualified state.
- Supporting the analytical instrument validation program to assure compliance with GQMS and AEQMS.
- Supporting the implementation and mitigation of gaps associated with the Data Integrity Plan.
- Working closely with System Owner, Manufacturing, QA, QC, IT and Validation groups.
Skills and Requirements:
- A degree in an appropriate science (Chemistry, Biology, Biochemistry, etc.) based discipline.
- Demonstrably significant experience in chosen degree discipline.
- Familiarity with the operation of analytical instruments and their operating systems.
- Familiarity with computerized system validation and data integrity.
- Experience of working with cross-functional teams of diverse people.
- Knowledge of cGMPs.
- High level of IT literacy and experience with IT applications (MS Office suite, eDocCompliance, LIMS, etc.).
- Familiarity with laboratory environments, analytical instruments and computerized systems. Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sarah Bershara at +267-477-3355, or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.